This is a webcast of the live New York session.Why you should attend
Join our expert faculty of health care and life sciences practitioners, in-house counsel, government regulators, and prosecutors as we examine the current state of health care and life sciences law and what the future might hold for affected parties. This program will cover the broad range of issues confronting the health care and life sciences industry: structuring of compliant financial and other relationships; recent developments in scientific discourse and promotional guidelines affecting FDA-regulated companies; and federal and state enforcement of health care fraud and abuse laws, including the federal False Claims Act, the federal Anti-Kickback Statute, the Stark law, and similar state laws.
What you will learn
- The legal framework for promoting drugs, biologics, and medical devices
- Legal requirements related to off-label promotion
- Recent developments in health care law and regulation
- Trends in health care fraud enforcement
- Best practices for compliance program effectiveness and internal investigations
Who should attend
This program is designed for health care attorneys (newly admitted and experienced) and allied professionals.
PLI Group Discounts
Groups of 4-14 from the same organization, all registering at the same time, for a PLI program scheduled for presentation at the same site, are entitled to receive a group discount. For further discount information, please contact membership@pli.edu or call (800) 260-4PLI.
PLI Can Arrange Group Viewing to Your Firm
Contact the Groupcasts Department via email at groupcasts@pli.edu for more details.
Cancellations
All cancellations received 3 business days prior to the program will be refunded 100%. If you do not cancel within the allotted time period, payment is due in full. You may substitute another individual to attend the program at any time.
All times are E.D.T.
Morning Session: 9:00 a.m. - 1:00 p.m. (E.D.T.)
9:00 Opening Remarks and Introduction
Scott D. Danzis, Karen S. Lovitch
9:15 FDA Regulation: Hot Topics
- Off-label communications
- FDA Enforcement: Advertising and Promotion, GMP/QSR, Adverse Event Reporting
- Biosimilars
- Mobile Medical Apps
- Diagnostics
Scott D. Danzis, Emily A. Alexander, Joshua Eizen
10:30 Networking Break
10:45 Sunshine Act Update
- Classification and valuation of payments and other transfers of value
- Interpretation of exceptions to the reporting requirements
- Dispute resolution process procedures
- Ownership reporting issues
Anita Griner (Invited), Karen S. Lovitch, Susan Hart-White, Kendra A. Martello
11:45 Enforcement Trends
- False Claims Act
- Anti-Kickback Statute
- Off-label promotion
- Individual liability
- Stark Law
Paul Kaufman, Laura F. Laemmle-Weidenfeld, Timothy P. McCormack
1:00 Lunch
Afternoon Session: 2:15 p.m. - 5:00 p.m. (E.D.T.)
2:15 Health Care & Life Sciences: Current Developments
- Implementation of health insurance exchanges and other health care reform issues
- Telemedicine/Telehealth
- Accountable care organizations/clinical integration
- Health information technology/electronic health records
Denise Hanna, David Hendren, Ellen L. Janos
3:30 Networking Break
3:45 Effective Compliance Programs and Investigations: A Hypothetical
- OIG and CMS expectations and requirements
- Strategies for assessing compliance program effectiveness
- Investigation best practices
- Privilege issues
- Self-disclosure
Stacy A. Friedman, Robert J. Rossi, Esquire, T. Reed Stephens, Robert A. Wells
5:00 Adjourn
Co-Chair(s)
Speaker(s)
Joshua Eizen ~ Office of Chief Counsel, U.S. Food and Drug Administration
Stacy A. Friedman ~ Senior Vice President and General Counsel, Brooklyn Hospital Center
Anita Griner(Invited) ~ Deputy Director, Data Sharing & Partnership Group, Center for Program Integrity, Centers for Medicare & Medicaid Services
Susan Hart-White ~ Associate General Counsel, Head of Regulatory Law, Privacy and Policy Group, Sanofi US
Paul Kaufman ~ Chief, Civil Health Care Fraud, United States Attorney's Office, Eastern District of New York
Program Attorney(s)
PLI makes every effort to accredit its Live Webcasts. Please check the CLE Calculator above for CLE information specific to your state.
PLI's Live Webcasts are approved for MCLE credit (
unless otherwise noted in the product description) in the following states/territories: Alabama, Alaska, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho*, Illinois, Indiana
1, Iowa*, Kansas*, Kentucky*, Louisiana, Maine*, Minnesota, Mississippi, Missouri, Montana, Nebraska, North Carolina, North Dakota, New Hampshire*, New Jersey, New Mexico, Nevada, New York
2, Ohio
3, Oklahoma, Oregon*, Pennsylvania
4, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia
5, Virgin Islands, Washington, West Virginia, Wisconsin, and Wyoming*.
*PLI will apply for credit upon request.
Arizona: The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement.
Arkansas and Oklahoma: Audio-only live webcasts are not approved for credit.
1Indiana: Considered a distance education course. There is a 6 credit limit per year.
2New York: Newly admitted attorneys may not take non-transitional course formats such as on-demand audio or video programs or live webcasts for CLE credit. Newly admitted attorneys not practicing law in the United States, however, may earn 12 transitional credits in non-traditional formats.
3Ohio: To confirm that the live webcast has been approved, please refer to the list of Ohio’s Approved Self Study Activities at http://www.sconet.state.oh.us. Online programs are considered self-study. Ohio attorneys have a 6 credit self-study limit per biennial compliance period. The Ohio CLE Board states that attorneys must have a 100% success rate in clicking on timestamps to receive ANY CLE credit for an online program.
4 Pennsylvania: A live webcast may be viewed individually or in a group setting. Credit may be granted to an attorney who views a live webcast individually. There is a 4.0 credit limit per year for this type of viewing. A live webcast viewed in a group setting receives live participatory credit if the program is open to the public and advertised at least 30 days prior to the program. Live webcasts viewed in a group setting that do not advertise at least 30 days prior the program will be considered "in-house", and therefore denied credit.
5Virginia: All distance learning courses are to be done in an educational setting, free from distractions.
Running time and CLE credit hours are not necessarily the same. Please be aware that many states do not permit credit for luncheon and keynote speakers.
Note that some states limit the number of credit hours attorneys may claim for online CLE activities, and state rules vary with regard to whether online CLE activities qualify for participatory or self-study credits. For more information, refer to your state CLE website or call Customer Service at (800) 260-4PLI (4754) or email: info@pli.edu.
If you have already received credit for attending some or the entire program, please be aware that state administrators do not permit you to accrue additional credit for repeat viewing even if an additional credit certificate is subsequently issued.